IRB Applications and Forms
The applications and forms shown below are updated on a regular basis. Please download a new copy each time you use them to ensure you are using the most current version. Also note that many of the forms/application have both a Behavioral/Social Sciences version and a Health Sciences version. Please make sure that you are using the correct type. Forms are available for download in MS Word (PC) and Rich Text Format (MAC) by clicking the "W" or "Apple" icons.
The SMOG Readability Tool is a recommended and tested method for determining the readability level of written materials.
Behavioral/Social Science Forms and Applications
| Behavioral/Social Sciences Application (Form #1124) |  |
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| Behavioral/Social Sciences Application Instructions | |
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| Behavioral/Social Sciences Continuing Review Application (Form #1129) | |
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| Behavioral/Social Sciences Continuing Review Application Instructions | |
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| Exemption Request (Form #1102) | |
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| Exemption Request Form Instructions | |
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| Specimen/Data Repository Application (Form #1103) | |
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| Specimen/Data Repository Application Instructions | |
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| Specimen/Data Continuing Review Application (Form #1137) | |
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| Umbrella Request (Form #1106) | |
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| Umbrella Request Instructions | |
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| Umbrella Continuing Review Application (Form #1113) | |
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| Umbrella Continuing Review Application Instructions | |
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Health Science Forms and Applications
| NEW 4/25/2008 |
Health Sciences Application (Form #1100) | |
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| NEW 4/25/2008 |
Health Sciences Application Instructions | |
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| Health Sciences Continuing Review Application (Form #1101) | |
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| Health Sciences Continuing Review Application Instructions | |
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| Coordinating Center Application (Form #1125) | |
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| Exemption Request (Form #1102) | |
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| Exemption Request Form Instructions | |
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| Specimen/Data Repository Application (Form #1103) | |
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| Specimen/Data Repository Application Instructions | |
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| Specimen/Data Continuing Review Application (Form #1137) | |
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| Umbrella Request (Form #1106) | |
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| Umbrella Request Instructions | |
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| Umbrella Continuing Review Application (Form #1113) | |
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| Umbrella Continuing Review Application Instructions | |
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Supplemental Forms
| Coordinating Center Supplemental Form (Form #1132) | |
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| CRC Supplemental Form (Clinical Research Center) | |
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| Specimen/Data Repository Supplemental Form (Form #1136) | |
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| Supplemental Form for Devices (Form #1134) | |
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| Supplemental Form for Devices - Instructions | |
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| NEW 4/25/2008 |
Supplemental Form for Drugs (Form #1135) | |
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| Vulnerable Population Form - Children (Form #1117) | |
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| Vulnerable Population Form Instructions - Children | |
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| Vulnerable Population Form - Cognitively Impaired (Form #1118) | |
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| Vulnerable Population Form Instructions - Cognitively Impaired | |
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| Vulnerable Population Form - Pregnant Women/Fetus/Neonate/Fetal Material (Form #1116) | |
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| Vulnerable Population Form Instructions - Pregnant Women/Fetus/Neonate/Fetal Material | |
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| Vulnerable Population Form - Prisoners (Form #1115) | |
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| Vulnerable Population Form Instructions - Prisoners | |
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HSRC/RDRC Applications
| FDA Form 2915 | |
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| Human Subjects Radiation (HSRC) Application (Form #1107) | |
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| Human Subjects Radiation (HSRC) Application Instructions | |
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| Radioactive Drug Research (RDRC) Application (Form #1108) | |
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| Radioactive Drug Research (RDRC) Application Instructions | |
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| Radiation Dose Calculator |
Informed Consent and Assent Documents
| Assent Document | |
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| Behavioral/Social Sciences - Standard Informed Consent Document | |
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| Health Sciences - Standard Informed Consent Document | |
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| Informed Consent Document - Short Form | |
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| Informed Consent Document - Emergency Use | |
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| Informed Consent, Assent, and Short Form Instructions | |
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| Informed Consent Document - Spanish Short Form | |
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| Spanish Short Form Instructions | |
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| Surrogate Rider for Informed Consent Document | |
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| Translator Declaration Statement | |
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Additional Forms
| Administrative Amendment Request (Form #1131) | |
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| Adverse Event Report (Form #1105) | |
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| Adverse Event Report Instructions | |
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| Adverse Event Reporting Flowchart | |
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| Amendment Request (Form #1104) | |
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| Amendment Request Instructions | |
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| Complaint Report (Form #1114) | |
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| Confidentiality Agreement | |
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| Conflict of Interest Opinion Request (Form #1120) | |
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| Conflict of Interest Decision Tree | |
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| Data Use Agreement (Form #1109) | |
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| FDA Form 1571 - Investigational New Drug Application (IND) | |
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| FDA Form 1572 - Statement of Investigator | |
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| FDA Form 2891 - Investigational New Device (IDE) (submit in triplicate) | |
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| Non-Human/Non-Research Determination Request (Form #1122) | |
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| Non-Human/Non-Research Determination Instructions | |
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| Protocol Deviation Report (Form #1123) | |
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| Protocol Deviation Report Instructions | |
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| MOU Site Checklist | |
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HIPAA Related Documents
| Authorization to Use/Disclose PHI (Form #1111) | |
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| Authorization to Use/Disclose PHI Instructions | |
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| NEW 4/18/2008 |
HIPAA Compliance (Form #1110) | |
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| NEW 4/18/2008 |
HIPAA Compliance Instructions | |
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| Waiver of Consent and/or Authorization to Access PHI (Form #1112) | |
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| Waiver of Consent and/or Authorization to Access PHI Instructions | |
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